Enfortumab Vedotin-ejfv

New evidence for established standard-of-care therapies, with updates for LORBRENA ® in ALK-positive metastatic non ‑ small cell lung cancer and a BRAFTOVI ® regimen in a type of BRAF-mutant colorectal cancer NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) will present new data across its diverse, industry-leading Oncology pipeline and portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 29 – June 2, 2026, in Chicago. Data from more than 40 company-sponsored, investigator-sponsored and collaborative research abstracts, including three late-breaking sessions and eight oral and rapid oral presentations, will be shared. These data highlight Pfizer’s leadership in establishing potential new standards of care across multiple cancer types and its next-generation pipeline of novel targets and combination strategies designed to extend impact into broader patient populations and earlier lines of therapy. “For people living with cancer and their families, every moment matters. We are moving with urgency to drive advances that have the potential to change standards of care – and striving to bring new, innovative options to patients in earlier lines of therapy,” said Jeff Legos, Chief Oncology Officer, Pfizer. “Our progress is evident in the data presented at ASCO this year, which span our portfolio of established therapies, as well as next-generation, early-stage clinical research from one of the industry’s largest oncology R&D programs. Together, these results reinforce our ability to advance breakthroughs that may redefine clinical practice and change the lives of people with cancer.” Key highlights of Pfizer’s presence at ASCO include: Sharing new evidence for standard-of-care therapies in certain types of biomarker-driven colorectal and lung cancers Seven-year update from the pivotal Phase 3 CROWN study further supports LORBRENA ® (lorlatinib) as a guideline-recommended first-line treatment for anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Late-breaking presentation of progression-free survival (PFS) and overall survival (OS) data from Cohort 3 of the BREAKWATER* trial evaluating BRAFTOVI ® (encorafenib) in combination with cetuximab and FOLFIRI (fluorouracil, leucovorin and irinotecan) as a first-line regimen for patients with BRAF V600E- mutant metastatic colorectal cancer (mCRC). These pivotal data further establish the benefit of this BRAFTOVI regimen following the U.S. Food and Drug Administration (FDA) full approval and the topline results announcement for objective response rate (ORR) from this Cohort earlier this year. Showcasing data on potential benefit of treatments in earlier lines of therapy for prostate and breast cancers Late-breaking presentation from the Phase 3 TALAPRO-3 study will highlight clinically meaningful radiographic progression-free survival (rPFS) benefit for TALZENNA ® (talazoparib) plus XTANDI ® ** (enzalutamide) in metastatic castration‑sensitive prostate cancer (mCSPC) patients with homologous recombination repair gene alterations, with effects consistent across subgroups and a strong OS trend. These data follow the announcement of topline results in March 2026 and support the potential of TALZENNA plus XTANDI to deliver benefit earlier in the disease course. Additional efficacy and safety outcomes by stratified subgroups from the Phase 3 HER2CLIMB-05 study investigating TUKYSA ® (tucatinib) in combination with trastuzumab and pertuzumab as first-line maintenance therapy for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC). These results support TUKYSA’s potential use as part of a chemotherapy-free, first-line maintenance strategy for HER2+ MBC. Advancing next-generation pipeline of novel mechanisms and differentiated combinations across solid tumors Updated Phase 2 data for PF‑08634404 (PF’4404), a novel bispecific antibody targeting PD-1 and VEGF, as monotherapy in first-line PD-L1-expressing NSCLC. PF’4404 is being developed as a potential backbone therapy across tumor types, including an ongoing Symbiotic-Lung-01 Phase 3 study in combination with chemotherapy in first-line NSCLC regardless of PD-L1 expression and an ongoing Symbiotic-GI-03 Phase 3 study in first-line mCRC. Updated results from a Phase 1 study of sigvotatug vedotin (SV), a novel integrin β6 (IB6)–directed ADC, in combination with pembrolizumab in NSCLC. These data support the ongoing SigVie-003 Phase 3 study of SV in combination with pembrolizumab in first-line NSCLC. An additional ongoing Phase 3 study, SigVie-002, is evaluating SV monotherapy in patients previously treated for advanced NSCLC. The first results from a Phase 2 study of neoadjuvant atirmociclib, a highly selective CDK4 inhibitor, in combination with letrozole versus letrozole alone in people with hormone receptor-positive (HR+), HER2- breast cancer. Atirmociclib is being developed as a potential first-in-class, next-generation cell cycle inhibitor backbone for HR+, HER2- breast cancer in the early adjuvant and first-line metastatic setting. Findings from a Phase 1b study of a brain-penetrant MEK inhibitor, PF-07799544 (polfurmetinib), plus a next-generation BRAF inhibitor, PF-07799933 (claturafenib), in advanced BRAF-mutant melanoma. Information on significant Pfizer and partner-sponsored abstracts, including date and time of presentation, follows in the chart below. A complete list of Pfizer and partner-sponsored abstracts and presentations is available here. LUNG CANCER Oral Presentation (Abstract 8502) May 29, 2026 1:00 PM-4:00 PM CDT Lorlatinib vs crizotinib as first-line treatment for advanced ALK+ non-small cell lung cancer: 7-year update from the phase 3 CROWN study Mok et al Rapid Oral Presentation (Abstract 8514) May 30, 2026 1:15 PM-2:45 PM CDT Updated results from a phase 2 trial of SSGJ-707 (PF-08634404), a PD-1/VEGF bispecific antibody, as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) Wu et al Poster Presentation (Abstract 8522) May 31, 2026 9:00 AM-12:00 PM CDT Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody-drug conjugate (ADC), plus pembrolizumab: updated results from phase 1 study (SGNB6A-001) Jaime et al Poster Presentation (Abstract 8609) May 31, 2026 9:00 AM-12:00 PM CDT Reduction in circulating tumor DNA (ctDNA) significantly correlates with radiographic response and tumor PD-L1 expression in a phase 1 study of PDL1V (PF-08046054) in patients with non-small cell lung cancer (NSCLC) Saleh et al COLORECTAL CANCER Oral Presentation (Abstract LBA3503) May 31, 2026 8:00 AM-11:00 AM CDT BREAKWATER: Progression-free survival analysis of first-line (1L) encorafenib + cetuximab (EC) + FOLFIRI in BRAF V600E-mutant metastatic colorectal cancer (mCRC) [LBA] Kopetz et al BREAST CANCER Oral Presentation (Abstract 1005) June 2, 2026 9:45 AM-12:45 PM CDT Efficacy and safety of tucatinib (TUC) vs placebo (PBO) combined with trastuzumab and pertuzumab (HP) as maintenance therapy for HER2+ metastatic breast cancer (MBC) by stratified randomized subgroups Hamilton et al Rapid Oral Presentation (Abstract LBA1018) May 31, 2026 11:30 AM-1:00 PM CDT Palbociclib plus Tamoxifen ± goserelin in women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer (BC): PATHWAY, an Asian international double-blind randomized phase 3 trial: Final Overall Survival (OS) analysis [LBA] Lu et al Poster Presentation (Abstract 518) June 1, 2026 1:30 PM-4:30 PM CDT Neoadjuvant atirmociclib plus letrozole versus letrozole alone in women with HR+/HER2− breast cancer: results from FOURLIGHT-2, a randomized phase 2 window of opportunity study Goel et al Poster Presentation (Abstract 1042) June 1, 2026 1:30 PM-4:30 PM CDT Tucatinib (TUC) combined with trastuzumab and pertuzumab (HP) as first-line (1L) maintenance therapy for HER2+ metastatic breast cancer (MBC): an in-depth safety analysis of HER2CLIMB-05 Dieras et al Poster Presentation (Abstract 1068) June 1, 2026 1:30 PM-4:30 PM CDT Long-term safety and adverse event (AE) management in patients with ER+/HER2− metastatic breast cancer (mBC) receiving prifestrastat, a first-in-class KAT6 inhibitor, in combination with fulvestrant Layman et al BLADDER/GENITOURINARY CANCERS Oral Presentation (Abstract LBA5007) May 30, 2026 3:00 PM-6:00 PM CDT TALAPRO-3: Talazoparib (TALA) + enzalutamide (ENZA) compared with placebo (PBO) + ENZA for the treatment of patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations [LBA] Agarwal et al Oral Presentation (Abstract 4507) May 29, 2026 2:45 PM-5:45 PM CDT Enfortumab vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC): 3.5-year follow-up and response analyses from the phase 3 EV-302 study Powles et al Oral Presentation (Abstract 4510) May 30, 2026 8:00 AM-9:30 AM CDT Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible: phase 3 KEYNOTE-905 study [MSD led] O’Donnell et al Oral Presentation (Abstract 5006) May 30, 2026 3:00 PM-6:00 PM CDT Final results from ZZFIRST: a randomized phase 2 trial of enzalutamide (EZ) and talazoparib (TALA) in metastatic hormone-naïve prostate cancer (mHNPC) Mateo et al Poster Presentation (Abstract 4613) May 31, 2026 9:00 AM-12:00 PM CDT Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants with cisplatin-ineligible muscle-invasive bladder cancer (MIBC): An analysis of clinically relevant subgroups in KEYNOTE-905 [MSD led] Adra et al Poster Presentation (Abstract 5043) May 31, 2026 9:00 AM-12:00 PM CDT Impact of baseline demographics on therapy management in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with talazoparib (TALA) + enzalutamide (ENZA) in the TALAPRO-2 study: extended follow-up De Giorgi et al MELANOMA Rapid Oral Presentation (Abstract 9512) May 30, 2026 4:30 PM-6:00 PM CDT Phase 1b study of a brain-penetrant MEK inhibitor, PF-07799544, plus next-generation BRAF dimer inhibitor, PF-07799933, in advanced BRAF-mutant melanoma Chen et al MULTIPLE MYELOMA Oral Presentation (Abstract 7500) May 29, 2026 2:45 PM-5:45 PM CDT Safety and efficacy of elranatamab as early intervention in patients with high-risk smoldering myeloma: First results from the phase 2 ERASMM (EMN34) study Touzeau et al OTHER GYNECOLOGICAL CANCERS Poster Presentation (Abstract 5627) June 1, 2026 9:00 AM-12:00 PM CDT A phase 2 study evaluating SSGJ-707 (PF-08634404), a PD-1/VEGF bispecific antibody, + chemotherapy (chemo) in patients (pts) with first-line (1L) advanced/recurrent endometrial cancer (EC) Zhou et al Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ASCO, which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries. *The BREAKWATER trial was conducted with support from ONO Pharmaceutical, Merck KGaA, Darmstadt, Germany and Eli Lilly and Company. Pierre Fabre Laboratories also has exclusive rights to commercialize the product in all other countries, including Europe and Asia (excluding Japan and South Korea). **XTANDI® is jointly developed and commercialized by Pfizer and Astellas in the United States. Prescribing Information for Pfizer Medicines Please see full Prescribing Information for LORBRENA® (lorlatinib). Please see full Prescribing Information for BRAFTOVI® (encorafenib). Please see full Prescribing Information for TALZENNA® (talazoparib). Please see full Prescribing Information for XTANDI® (enzalutamide). Please see full Prescribing Information for TUKYSA® (tucatinib). About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematologic malignancies, and lung cancers. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. 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Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this regimen would be the first and only perioperative treatment for patients with MIBC regardless of cisplatin eligibility, marking a potential new standard of care April 20, 2026 -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for perioperative (before and after surgery) PADCEV™ (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, in combination with the PD-1 inhibitor Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) as treatment for patients with muscle-invasive bladder cancer (MIBC). This regimen was FDA-approved in November 2025 for use as perioperative treatment in cisplatin-ineligible patients with MIBC. This filing seeks to expand the indication to patients with MIBC regardless of cisplatin eligibility. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where limited therapy options exist.i Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of August 17, 2026. Moitreyee Chatterjee-Kishore, PhD, MBA, Head of Oncology Development, Astellas "The data from the EV-304 trial take us another step closer to bringing perioperative enfortumab vedotin plus pembrolizumab to patients with muscle-invasive bladder cancer regardless of cisplatin eligibility, who still face a recurrence rate of more than fifty percent despite curative-intent surgery, highlighting the ongoing need for improved treatment strategies." Jeff Legos, PhD, MBA, Chief Oncology Officer, Pfizer "For people with muscle‑invasive bladder cancer, surgery is often just the beginning of a long and uncertain journey, with far too many patients seeing their cancer return. If approved, perioperative PADCEV plus pembrolizumab could meaningfully change that experience, potentially helping patients reduce the risk of recurrence and live longer, regardless of whether they are eligible for cisplatin." The sBLA submission was based on data from the Phase 3 EV-304 clinical trial (also known as KEYNOTE-B15), evaluating perioperative enfortumab vedotin in combination with pembrolizumab in patients with MIBC eligible for cisplatin-containing chemotherapy. Results from EV-304, presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), showed a 47% reduction in the risk of tumor recurrence, progression or death and a 35% reduced risk of death for perioperative enfortumab vedotin in combination with pembrolizumab compared to standard of care neoadjuvant (before surgery) gemcitabine and cisplatin chemotherapy.ii The combination also demonstrated a pathological complete response (pCR) rate of 55.8% compared with 32.5% pCR rate in the chemotherapy arm at the time of surgery.ii The safety profile for perioperative enfortumab vedotin plus pembrolizumab observed in EV-304 was consistent with prior experience with the combination and there were no new safety signals.ii These data will be discussed with additional global health authorities for potential regulatory filings. The EV-304 trial is an ongoing, open-label, randomized, controlled, Phase 3 study evaluating perioperative enfortumab vedotin in combination with pembrolizumab versus neoadjuvant chemotherapy (gemcitabine and cisplatin) in patients with MIBC who are eligible for cisplatin-based chemotherapy. Patients were randomized to receive either neoadjuvant and adjuvant (before and after surgery) enfortumab vedotin in combination with pembrolizumab (arm A) or neoadjuvant chemotherapy (arm B). Curative-intent surgery (cystectomy) was performed in both arms. Enfortumab vedotin in combination with pembrolizumab was administered as a planned total of 9 cycles of enfortumab vedotin and 17 cycles of pembrolizumab split before and after surgery.iii The primary endpoint of this trial is EFS, defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes radical cystectomy (RC) or failure to undergo RC in participants with residual disease, gross residual disease left behind at the time of surgery, local or distant recurrence based on blinded independent central review (BICR) or death due to any cause. Key secondary endpoints include OS and pCR rate.iii Bladder cancer is the ninth most common cancer worldwide, diagnosed in more than 614,000 people each year globally, including an estimated 85,000 people in the U.S.iv,v MIBC represents approximately 30% of all bladder cancer cases.vi The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery.vii However, even after undergoing surgery, half of patients with MIBC experience disease recurrence.viii PADCEV™ (enfortumab vedotin-ejfv) is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.ix Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4-expressing cells, followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).x PADCEV plus pembrolizumab is approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in the United States, the European Union, Japan and a number of other countries around the world. PADCEV is also approved as a single agent for the treatment of adult patients with la/mUC who have previously received a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy or are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.x Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and multispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world's most common cancers, including breast cancer, gastrointestinal cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. Seagen and Astellas entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV™ (enfortumab vedotin) and Merck's Keytruda® (pembrolizumab) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. Keytruda is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). i Priority Review. US FDA. https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review. Accessed February 24, 2026. ii Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin: randomized, open-label, phase 3 KEYNOTE-B15 study. Abstract #LBA630. 2026 American Society of Clinical Oncology Genitourinary (ASCO GU) Congress. iii National Institute of Health. National Library of Medicine. Perioperative Enfortumab Vedotin (EV) Plus Pembrolizumab (MK-3475) Versus Neoadjuvant Chemotherapy for Cisplatin-Eligible Muscle Invasive Bladder Cancer (MIBC) (MK-3475-B15/ KEYNOTE-B15 / EV-304) (KEYNOTE-B15). ClinicalTrials.gov identifier: NCT04700124. Published January 7, 2021. Updated August 26, 2025. Accessed February 24, 2026. Available at: https://www.clinicaltrials.gov/study/NCT04700124. iv World Bladder Cancer Patient Coalition. GLOBOCAN 2022: Bladder cancer 9th most common worldwide. Accessed February 24, 2026. Available at: https://worldbladdercancer.org/news_events/globocan-2022-bladder-cancer-is-the-9th-most-commonly-diagnosed-worldwide/ v American Cancer Society. Cancer Facts & Figures 2025. Accessed February 24, 2026. Available at: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2025-cancer-facts-figures.html vi Bladder Cancer Awareness Network. What is Muscle Invasive Bladder Cancer? Accessed February 24, 2026. Available at: https://bcan.org/what-is-muscle-invasive-bladder-cancer/#:~:text=When%20tumors%20grow%20into%20or,Virginia%20Health%20System%20explain% 20MIBC vii Funt SA, Rosenberg JE. Systemic, perioperative management of muscle-invasive bladder cancer and future horizons. Nat Rev Clin Oncol. 2017 Apr;14(4):221-234. doi: 10.1038/nrclinonc.2016.188. Epub 2016 Nov 22. PMID: 27874062; PMCID: PMC6054138. viii Squires P, Cook EE, Song Y, Wang C, Zhang A, Seshasayee SM, Rogiers A, Li H, Mamtani R. Treatment Patterns, Disease Recurrence, and Overall Survival in Patients with Muscle-Invasive Bladder Cancer after Radical Cystectomy: A Population-Level Claims-Based Analysis. Clinical Genitourinary Cancer. 2025 Nov;102466. https://doi.org/10.1016/j.clgc.2025.102466. ix Challita-Eid PM, Satpayev D, Yang P, et al. Enfortumab vedotin antibody-drug conjugate targeting nectin-4 is a highly potent therapeutic agent in multiple preclinical cancer models. Cancer Res 2016;76(10):3003-13. x PADCEV [package insert]. Northbrook, IL: Astellas Pharma US, Inc. The content above comes from the network. if any infringement, please contact us to modify.